Karen De Vreese, PhD, is Principal CMC Manager at Ardena. She brings nearly 30 years of experience across the pharmaceutical and life sciences industry, with extensive expertise in regulatory affairs and CMC documentation.
Throughout her career, Karen has supported global pharmaceutical companies in the preparation, submission, and life cycle management of regulatory dossiers across multiple international markets, including Europe, the United States, Canada, Japan, China, and Russia. Her expertise includes the development of Module 2 (Quality Overall Summary) and Module 3 documentation for both small molecules and biologicals, as well as post-approval variations, responses to regulatory questions, and clinical trial documentation, including IMPDs and INDs. At Ardena, she works closely with clients and project teams to support high-quality regulatory submissions and ongoing dossier maintenance throughout the product life cycle. She also assesses the regulatory impact of change controls to support compliant implementation of development and manufacturing changes.
Karen obtained her PhD in Medical Sciences from the University of Leuven. She began her career in virology research before transitioning into clinical development and regulatory affairs roles, combining scientific expertise with broad regulatory knowledge across development and commercial programs.
